MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-10-26 for ADVIA CENTAUR XPT manufactured by Siemens Healthcare Diagnostics Inc..
[90964346]
The customer contacted the siemens customer care center (ccc). A siemens customer service engineer (cse) was dispatched to the customer's site. The service was performed over multiple visits. The cse found no system issues. The cse checked the wash manifold, aspiration of probe 1,2,3 and 4, vacuum pump, aspiration performance, dispense performance, sample syringe and diluter and verified that the volumes were accurate and consistent , and checked reagent packs, incubation ring magnet, acid and base dispense, which were acceptable. The cse verified that the luminometer was dry and clean. The cse performed luminometer darkcounts and results were acceptable. The cse tested dry, wet water, and wet wash and provided results, which were acceptable. The cse performed precision testing of 30 replicates to verify precision of estradiol, psa, and vitamin b12, which were acceptable. The cause of the discordant psa result is unknown. The instrument is performing according to specifications. No further evaluation of the device is required. Mdr 2432235-2017-00582 was filed for the same event. Mdr 2432235-2017-00583 was filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[90964347]
Inconsistent prostate specific antigen (psa) results were obtained, between the initial and repeat runs, on one patient sample on a advia centaur xpt instrument. The sample was repeated twice on the same instrument, resulting higher than the initial result. It is unknown which result was discordant and if the result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant psa result(s).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00578 |
| MDR Report Key | 6981539 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-26 |
| Date of Report | 2017-11-01 |
| Date of Event | 2017-10-04 |
| Date Mfgr Received | 2017-10-27 |
| Device Manufacturer Date | 2016-11-07 |
| Date Added to Maude | 2017-10-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | MANUFACTURING LIMITED REGISTRATION NUMBER: 8020888 |
| Manufacturer City | CHAPEL LANE, SWORDS, CO, DUBLIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XPT |
| Generic Name | ADVIA CENTAUR XPT |
| Product Code | LTJ |
| Date Received | 2017-10-26 |
| Model Number | ADVIA CENTAUR XPT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN, NY NY 10591 US 10591 |
| Brand Name | ADVIA CENTAUR XPT |
| Generic Name | ADVIA CENTAUR XPT |
| Product Code | JJE |
| Date Received | 2017-10-26 |
| Model Number | ADVIA CENTAUR XPT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN, NY NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-26 |